Venous valve, system and method

ABSTRACT

A venous valve with a frame and a cover on the frame for unidirectional flow of a liquid through the valve.

CROSS-REFERENCE TO RELATED U.S. APPLICATIONS

This application is a continuation of U.S. Ser. No. 14/678,430, filedApr. 3, 2015, which is a continuation of U.S. Ser. No. 13/226,172, filedSep. 6, 2011, which is a continuation of U.S. Ser. No. 11/150,331, filedJun. 10, 2005, now U.S. Pat. No. 8,012,198, each of which isincorporated by reference, herein.

FIELD OF THE INVENTION

The present invention relates to apparatus, systems, and methods for usein a lumen; and more particularly to a valve apparatus, systems, andmethods for use in the vasculature system.

BACKGROUND OF THE INVENTION

The venous system of the legs uses valves and muscles as part of thebody's pumping mechanism to return blood to the heart. Venous valvescreate one way flow to prevent blood from flowing away from the heart.When valves fail, blood can pool in the lower legs resulting in swellingand ulcers of the leg. The absence of functioning venous valves can leadto chronic venous insufficiency.

Techniques for both repairing and replacing the valves exist, but aretedious and require invasive surgical procedures. Direct and indirectvalvuoplasty procedures are used to repair damaged valves. Transpositionand transplantation are used to replace an incompetent valve.Transposition involves moving a vein with an incompetent valve to a sitewith a competent valve. Transplantation replaces an incompetent valvewith a harvested valve from another venous site. Prosthetic valves canbe transplanted into the venous system, but current devices are notsuccessful enough to see widespread usage.

BRIEF DESCRIPTION OF THE DRAWINGS

Figs. IA and 1B illustrate an embodin1ent of a valve according to thepresent invention.

Fig. I C illustrates a cross-sectional view of the valve illustrated inFig. I A.

Fig. ID illustrates a cross-sectional view of the valve illustrated inFIG. 1B.

Figs. IE and IF illustrates an additional perspective view of the valveillustrated in Fig. IA.

FIGS. 2A and 2B illustrate an embodiment of a valve in an expanded andcollapsed state according to the present invention.

FIGS. 3A and 3B illustrate an embodin1ent of a valve according to thepresent invention.

FIG. 4A illustrates an embodiment of a valve according to the presentinvention.

FIG. 4B illustrates an embodiment of a valve according to the presentinvention.

FIG. 5A illustrates an embodiment of a valve according to the presentinvention.

FIG. 5B illustrates an embodiment of a frame for the valve illustratedin FIG. 5A according to the present invention.

FIG. 6 illustrates an embodiment of a system that includes a valveaccording to the present invention.

FIG. 7 illustrates an embodiment of a system that includes a valveaccording to the present invention.

FIG. 8 illustrates an embodiment of a system that includes a valveaccording to the present invention.

FIGS. 9A, 9B and 9C illustrate an embodiment of a system that includes avalve according to the present invention.

FIGS. 10A, 10B and 10C illustrate an embodiment of a system thatincludes a valve and a catheter having radiopaque markers according tothe present invention.

DETAILED DESCRIPTION

Embodiments of the present invention are directed to an apparatus,system, and method for valve replacement or augmentation. For example,the apparatus can include a valve that can be used to replace or augmentan incompetent valve in a body lumen. Embodiments of the valve caninclude a frame and cover that can be 30 implanted throughminimally-invasive techniques into the body lumen. In one example,embodiments of the apparatus, system, and method for valve replacementor augmentation may help to maintain antegrade blood flow, whiledecreasing retrograde blood flow in a venous system of individualshaving venous insufficiency, such as venous insufficiency in the legs.

The figures herein follow a numbering convention in which the firstdigit or digits correspond to the drawing figure number and theremaining digits identify an element or component in the drawing.Similar elements or components between different figures may beidentified by the use of similar digits. For example, 110 may referenceelement “10” in FIG. 1, and a similar element maybe referenced as 210 inFIG. 2. As will be appreciated, elements shown in the variousembodiments herein can be added, exchanged, and/or eliminated so as toprovide a number of additional embodiments of valve. In addition,discussion of features and/or attributes for an element with respect toone Fig. can also apply to the element shown in one or more additionalFigs. Embodiments illustrated in the figures are not necessarily toscale.

FIGS. 1A through 5B provide illustrations of various embodiments of avalve of the present invention. The valve can be implanted within thefluid passageway of a body lumen, such as for replacement oraugmentation of a valve structure within the body lumen (e.g., a venousvalve). In one embodiment, the valve of the present invention may bebeneficial to regulate the flow of a bodily fluid through the body lumenin a single direction.

FIGS. 1A-1F illustrate one embodiment of a venous valve 100. Venousvalve 100 includes a frame 102 and a cover 104 for the venous valve 100,where both the frame 102 and the cover 104 can resiliently radiallycollapse and expand, as will be described herein. Among other things,the frame 102 and the cover 104 define a lumen 106 of the valve 100. Thelumen 106 allows for, amongst other things, fluid (e.g., blood) to movethrough the valve 100. The frame 102 also includes a first end 108 and asecond end 110. The first end 108 and the second end 110 define a lengthof the frame 102 and of the valve 100. In one embodiment, the length ofvalve 100 can have a number of values. As will be appreciated, thelength of valve 100 can be determined based upon the location into whichthe valve 100 is to be implanted. In other words, the length of thevalve 100 can be patient specific. Examples of values for the lengthinclude, but are not limited to, 12 millimeters to 32 millimeters. Othervalues are also possible.

The frame 102 further includes an outer surface 112 and an inner surface114 opposite the outer surface 112. In one embodiment, the cover 104 canbe located over at least the outer surface 112 of the frame 102. Forexample, the cover 104 can extend around a perimeter of the frame 102 soas to completely cover the outer surface 112 of the frame 102. In otherwords, the cover 104 extends over the outer surface 112 of the frame 102so that there are no exposed portions of the outer surface 112 of theframe 102. In an additional embodiment, the cover 104 can also belocated over at least the inner surface 114 of the frame 102, asillustrated in FIGS. 1A-1F. A further embodiment includes the cover 104located over at least a portion of the outer surface 112 and at least aportion of the inner surface 114.

The cover 104 can further include surfaces defining a reversiblysealable opening 116 for unidirectional flow of a liquid through thelumen 106. For example, the surfaces of the cover 104 can be deflectablebetween a closed configuration in which fluid flow through the lumen 106can be restricted and an open configuration in which fluid flow throughthe lumen 106 can be permitted.

The frame 102 can be formed from a wide variety of materials and in awide variety of configurations. Frame 102 can have a unitary structurewith an open frame configuration. For example, the open frameconfiguration can include frame members 118 that define openings 120across the frame 102 through which valve leaflets 122 formed by thecover 104 can radially-collapse and radially-expand, as will bedescribed herein.

In addition, the first end 108 and the second end 110 each include aplurality of end portions 124 that lay on a common plane. The pluralityof end portions 124, however, need not all lay on the common plane. Inother words, it is possible that one or more of the end portions 124 ofthe frame 102 lay above and/or below the common plane.

While the frames illustrated herein, for example frame 102, are shown ashaving a circular configuration, other configurations are also possible.For example, the frame 102 could have an elliptical configuration. Assuch, the present invention should not be limited to the illustration ofthe frames, such as frame 102, provided herein.

As illustrated in FIGS. 1A-1F, the frame 102 can further include a firstleaflet connection region 126 and a second leaflet connection region 128adjacent the second end 110 of the frame 102. The first and secondleaflet connection regions 126 and 128 further include an opening 130through the frame 102. In the present example, the cover I 04 can becoupled, as described more fully herein, to at least the first leafletconnection region 126 and the second leaflet connection region I28 usingthe openings 130 through the frame 102. The cover 104 so coupled canthen move (e.g., pivot) relative the first leaflet connection region 126and the second leaflet connection region 128 between an open valveconfiguration (illustrated in FIGS. 1A, 1C, and IE) and a closed valveconfiguration (illustrated in Figs. IB, ID, and IF). As illustrated inthe closed valve configuration, the open frame configuration of frameI02 allows cover 104 to move through the openings 120 in creating thereversible sealable opening 116 of the valve 100.

As illustrated in FIGS. 1A-IB and IE-IF, the first leaflet connectionregion I26 and the second leaflet connection region 128 can bepositioned opposite each other along a common axis. In addition, thefirst leaflet connection region 126 and the second leaflet connectionregion 128 can be radially symmetric around the longitudinal centralaxis 132 of the frame 102.

As illustrated, the first leaflet connection region 126 and the secondleaflet connection region 128 can be positioned approximately onehundred eighty (180) degrees relative each other around the longitudinalcentral axis 132 of the frame 102. As will be appreciated, the first andsecond leaflet connection regions 126, 128 need not necessarily displayan equally spaced symmetrical relationship as described above in orderto practice the embodiments of the present invention. For example, theradial relationship can have the first and second leaflet connectionregion 126, 128 positioned at values greater than one hundred eighty(180) degrees and less than one hundred eighty (180) degrees relativeeach other around the longitudinal central axis 132 of the frame 102.

The frame member 118 of frame 102 can have similar and/or differentcross-sectional geometries and/or cross-sectional dimensions along itslength. The sin1ilarity and/or the differences in the cross-sectionalgeometries and/or cross-sectional dimensions can be based on one or moredesired functions to be elicited from each portion of the frame 102. Forexample, the frame member 118 can have a similar cross-sectionalgeometry along its length. Examples of cross-sectional geometriesinclude, but are not limited to, round (e.g., circular, oval, and/orelliptical), rectangular geometries having perpendicular sides, one ormore convex sides, or one or more concave sides; semi-circular;triangular; tubular; I-shaped; T shaped; and trapezoidal.

Alternatively, the cross-sectional dimensions of one or more geometriesof the frame member 118 can change from one portion of the frame 102 toanother portion of the frame 102. For example, portions of the framemember 118 can taper (i.e., transition) from a first geometric dimensionto a second geometric dimension different than the first geometricdimension. These embodin1ents, however, are not limited to the presentexamples as other cross-sectional geometries and dimension are alsopossible. As such, the present invention should not be limited to theframes provided in the illustration herein.

The valve 100 can further include a radial support member 134. Theradial support member 134 can include a number of differentconfigurations, as will be described herein. For example, as illustratedthe radial support member 134 couples first leaflet connection region126 and the second leaflet connection region 128. In addition tocoupling the connection regions 126 and 128, the radial support member134 can also serve to stabilize the relative positions of the connectionregions 126 and 128 (e.g., lin1it relative fluctuations of theconnection regions 126 and 128).

In the present embodiment, the radial support member 134 can be in theform of a tubular ring 136. The tubular ring 136 joins to the firstleaflet connection region 126 and the second leaflet connection region128. The tubular ring 136 can also move radially with the first andsecond leaflet connection region 124, 126 as the valve 100 radiallycollapses and expands.

In the various embodiments described herein, the tubular ring 136 can beconfigured to provide a spring force (e.g., elastic potential energy) tocounter radial compression of the frame 102 towards its uncompressedstate. For example, the tubular ring 136 can have a zig-zagconfiguration that includes corners 138 in from which a spring force(e.g., elastic potential energy) can be derived when the frame 102 iscompressed. As will be appreciated, the corners 138 can have a number ofconfigurations, including turns defining angles and/or arcs (e.g.,having a radius of curvature). Additional spring force can be impartedto the frame 102 from the compression of the corners adjacent the firstand second leaflet connection regions 126, 128 as well.

The valve 100 can further include a second tubular ring 140 located atthe first end 108 of the frame 102. The second tubular ring 140 can havea similar, or 5 different, configuration as tubular ring 136 so as toimpart the spring force to counter radial compression of the frame 102towards its uncompressed state. In one embodiment, both the tubular ring136 and the second tubular ring 140 help to stabilize the relativepositions of the connection regions 126 and 128, as described herein,and to help maintain the position of the connection regions 126 and 128relative the walls of a lumen in which the valve 100 has been implanted.As will be appreciated, the valve 100 could further include additionaltubular rings located at one or more positions along the frame 102.

The compressible nature of the valve 100 can accommodate changes in bodylumen size (e.g., diameter of the body lumen) by flexing to expandand/or contract to change the diameter of the frame 102. In oneembodiment, the corner portions of the tubular rings 136 and 140, andthe first leaflet connection region 126 and the second leafletconnection region 128 can act as springs to allow the valve 100 toresiliently radially collapse and expand. The frame 102 can also providesufficient contact and expansion force with the surface of a body lumenwall to encourage fixation of the valve 100 and to prevent retrogradeflow within the body lumen around the edges of the frame 102 and thesurface of a lumen when combined with a closed state of the valveleaflets attached thereto. Anchoring elements (e.g., barbs) can also beincluded with valve 100.

FIGS. 2A and 23 provide an example of the valve 200 in a collapsed state(FIG. 2A) and in an expanded state (FIG. 2B). As shown in FIGS. 2A and2B, the valve 200 can travel between the collapsed and the expandedstate along a radial travel path 240 (as shown in FIG. 2B), where therecan be a change in a cross sectional area of lumen 206. For example, theframe 202 can travel along the radial travel path 242 so as to change awidth of lumen 206. This can allow the valve 200 to react appropriatelyto the distension and contraction of a body lumen in which the valve 200is placed.

Referring again to FIGS. 1A-1F, the corner portions of the tubular rings136 and 140, and the first and second leaflet connection region 126 and128 can also include, but are not limited to, other shapes that allowfor repeatable travel between the collapsed state and the expandedstate. For example, the elastic regions can include integrated springshaving a circular or an elliptical loop configuration. The embodimentsare not, however, limited to these configurations as other shapes arealso possible.

The frame member 118 forming the tubular rings 136 and 140 can alsoinclude a radial flare 144. As illustrated, the radial flare 144provides for an increase in the peripheral frame dimension at the firstend 108 and/or the second end 110 of the frame 102. In one embodiment,the frame members 118 can be pre and/or post-treated to impart theradial flare 144. For example, frame members 118 forming the tubularrings 136 and 140 of the frame 102 could be bent to impart the radialflare 144. The frame 102 could then be heat treated so as to fix theradial flare 144 into the frame member 118. Other material treatments(e.g., plastic deformation, forging, elastic deformation with heatsetting) are also possible to impart the radial flare as describedherein, many of which are material specific.

The embodiments of the frame described herein can also be constructed ofone or more of a number of materials and in a variety of configurations.The frame embodiments can have a unitary structure with an open frameconfiguration. The frame can also be self-expanding. Examples ofself-expanding frames include those formed from temperature-sensitivememory alloy which changes shape at a designated temperature ortemperature range, such as Nitinol. Alternatively, the self-expandingframes can include those having a spring-bias. In addition, the frame102 can have a configuration that allows the frame embodiments beradially expandable through the use of a balloon catheter.

The embodiments of the frame, such as frame 102 in FIGS. 1A-1F, can alsobe formed from one or more contiguous frame members. For example, theframe member 118 of frame embodiments can be a single contiguous member.The single contiguous member can be bent around an elongate tubularmandrel to form the frame. The free ends of the single contiguous membercan then be welded, fused, crimped, or otherwise joined together to formthe frame. In an additional embodiment, the frame member 118 of frame102 can be derived (e.g., laser cut, water cut) from a single tubularsegment. In an alternative embodin1ent, methods of joining the framemember 118 to create the elastic region include, but are not limited to,welding, gluing, and fusing the frame member. The frame 102 can be heatset by a method as is typically known for the material which forms theframe 102.

The frame embodiments can be formed from a number of materials. Forexample, the frame can be formed from a biocompatible metal, metalalloy, polymeric material, or combination thereof As described herein,the frame can be self-expanding or balloon expandable. In addition, theframe can be configured so as to have the ability to move radiallybetween the collapsed state and the expanded state. Examples of suitablematerials include, but are not limited to, medical grade stainless steel(e.g., 316L), titanium, tantalum, platinum alloys, niobium alloys,cobalt alloys, alginate, or combinations thereof Additional frameembodiments may be formed from a shape-memory material, such as shapememory plastics, polymers, and thermoplastic materials. Shaped memoryalloys having 5>uperela5>tic properties generally made from ratios ofnickel and titanium, commonly known as Nitinol, are also possiblematerials. Other materials are also possible.

The lumen 106 can include a number of sizes. For example, the size ofthe lumen can be determined based upon the type of body lumen and thebody lumen size in which the valve is to be placed. In an additionalexample, there can also be a minimum value for the width for the framethat ensures that the frame will have an appropriate expansion forceagainst the inner wall of the body lumen in which the valve is beingplaced.

In one embodiment, the frame can further include one or more activeanchoring elements. For example, the one or more active anchoringelements can include, but are not limited to, one or more barbsprojecting from the frame 102.

The valve can further include one or more radiopaque markers (e.g.,tabs, sleeves, welds). For example, one or more portions of the framecan be formed from a radiopaque material. Radiopaque markers can beattached to, electroplated, dipped and/or coated onto one or morelocations along the frame. Examples of radiopaque material include, butare not limited to, gold, tantalum, and platinum.

The position of the one or more radiopaque markers can be selected so asto provide information on the position, location and orientation (e.g.,axial, directional, and/or clocking position) of the valve during itsimplantation. For example, radiopaque markers can be configured radially(e.g., around the radial support members 132 and 134) and longitudinally(e.g., on predetermined portions of longitudinally extending framemembers 118) on predetermined portions of the frame 102 to allow theradial and axial position of the frame 102 to be determined. So in oneembodiment a radiograph image of the frame 102 taken perpendicular tothe valve leaflets 122 in a first clock position can produce a firstpredetermined radiograph image (e.g., an imaging having the appearanceof an inverted “Y”) and a radiographic image taken perpendicular to thefirst and second leaflet connection regions 126, 128 in a second clockposition can produce a second predetermined radiograph image (e.g., animaging having the appearance of an upright “Y”) distinguishable fromthe first predetermined radiograph image.

In one embodiment, the first and second predetermined radiograph imagesallow the radial position of the leaflets 122 to be better identifiedwithin the vessel. This then allows a clocking position for the valve100 to be determined so that the valve can be positioned in a morenatural orientation relative the compressive forces the valve willexperience in situ. In other words, determining the clocking of thevalve as described herein allows the valve to be radially positioned insame orientation as native valve that it's replacing and/or augmenting.

As described herein, valve 100 further includes cover 104 havingsurfaces defining the reversibly scalable opening 116 for unidirectionalflow of a liquid through the lumen 106. In one embodiment, the cover 104extends over at least a portion of the frame 102 to the first and secondleaflet connection regions 126, 128. The cover 104 extends between thefirst and second leaflet connection regions 126, 128 to provide a firstvalve leaflet 146 and a second valve leaflet 148 of the valve leaflets122. The first and second valve leaflets 146, 148 include surfacesdefining the reversibly sealable opening 116 extending between the firstand second leaflet connection regions 126, 128 for unidirectional flowof a liquid through the valve 100.

In one embodiment, the material of the cover 104 can be sufficientlythin and pliable so as to permit radially-collapsing of the valveleaflets 122 for delivery by catheter to a location within a body lumen.The valve leaflets 122 can be constructed of a fluid-impermeablebiocompatible material that can be either synthetic or biologic.Possible synthetic materials include, but are not limited to, expandedpolytetrafluoroethylene (ePTFE), polytetrafluoroethylene (PTFE),polystyrene-polyisobutylene-polystyrene (SIBS), polyurethane, segmentedpoly(carbonate-urethane), Dacron, polyethlylene (PE), polyethyleneterephthalate (PET), silk, Rayon, Silicone, or the like. Possiblebiologic materials include, but are not limited to, autologous,allogeneic or xenograft material. These include explanted veins anddecellularized basement membrane materials (such as noncrosslinkedbladder membrane or amnionic membrane), such as small intestinesubmucosa (SIS) or umbilical vein. As will be appreciated, blends ormixtures of two or more of the materials provided herein are possible.For example, SIBS can be blended with one or more basement membranematerials.

As described herein, a number of methods exist for attaching the cover104 to the frame 102 so as to form the valve leaflets 122. For example,when positioned over the inter surface 114 of the frame 102, the cover104 can be secured to the frame members 118 through the use ofbiocompatible staples, glues, sutures or combinations thereof. In anadditional embodiment, the cover I04 can be coupled to the frame members118 through the use of heat sealing, solvent bonding, adhesive bonding,or welding the cover 104 to either a portion of the cover 104 (i.e.,itself) and/or the frame 102.

With respect to coupling the cover 104 to the first and second leafletconnection regions 126, 128, the cover 104 can be passed from the innersurface 114 and wrapped around at least a portion of the outer surface112 adjacent the connection regions. For example, securing the cover 104at the first and second leaflet connection regions 126, 128 can beaccomplished by making longitudinal cuts of a predetermined length intothe cover 104 adjacent the first and second leaflet connection regions126, 128. In one embodiment, each cut creates two flaps adjacent each ofthe first and second leaflet connection regions 126, 128. The flaps canthen pass through the frame adjacent the first and second leafletconnection regions 126, 128 and each of the two resulting flaps can bewrapped from the inner surface 114 around the frame 102 to the outersurface 112. The cover 104 can then be coupled to itself and/or theframe 102, as described herein. In addition, sutures can be passedthrough the opening 130 and the cover 104 so as to secure the cover 104to the frame 102. In one embodiment, providing the flaps as describedallows for the cover 104 to create a more fluid tight opening 116 in thearea adjacent the first and second connection regions 126, 128.

As illustrated, the valve leaflets 122 include a region 150 of the cover104 that can move relative the frame 102. The region 150 of the cover104 can be unbound (i.e., unsupported) by the frame 102 and extendsbetween the first and second leaflet connection regions 126, 128. Thisconfiguration permits the reversibly sealable opening 116 to open andclose in response to the fluid pressure differential across the valveleaflets 122.

In an additional embodiment, the valve leaflets 122 in their openconfiguration have a circumference that is less than the circumferenceof the frame 102. For example, as illustrated, the valve leaflets 122 intheir open configuration (FIG. 1A) include a transition region 152 wherethe circumference of the cover 104 changes from a first circumference toa second circumference that is smaller than the first circumference. Inone embodiment, this better ensures that the valve leaflets 122 do notcome into contact with the inner wall of the vessel in which the valve100 is implanted.

In addition, the transition region 152 allows for a gap 154 between theouter surface of the valve leaflets 122 and the inner wall of the vesselin which the valve 100 is implanted. In one embodiment, the gap 154 canhelp prevent adhesion between the valve leaf1ets 122 and the vessel walldue to the presence of a volume of blood there between. The gap 154 canalso allow for retrograde blood How to be collected as the process ofclosing the valve leaflets 122 starts.

In one embodiment, the reversible scalable opening 116 also includes alip 156. The lip 156 can have either a non-planar or a planarconfiguration. In one embodiment, whether the lip 156 has a planar ornon-planar configuration can depend on what material is selected forforming the valve leaflets 122. For example, when a stiffer material(e.g., PTFE) is used for the valve leaflets 122 the lip 156 can havemore of a concave shape than a planar or straight shape. In other words,as illustrated in FIGS. 1A and 1E, the lip 156 transitions from a firstposition adjacent the first and second leaflet connection regions 126,128 to a second position lower than the first position as illustratedapproximately midway between the first and second leaflet connectionregions 126, 128. So, the lip 156 dips down to a low point approximatelymidway between the first and second leaflet connection regions 126, 128.In one embodiment, this shape allows the lip 156 to form a catenary whenthe valve leaflets 122 are in their closed position, as illustrated inFIG. 1F. In an alternative embodiment, when an elastic material is usedfor the valve leaflets 122 the lip 156 has more of a straight or planarshape. In other words, the lip 156 maintains essentially the samerelative position around the circumference of the valve leaflets 122.

As will be appreciated, the lip 156 when the valve leaflets 122 are intheir open configuration can have a non-round shape. For example, thelip 156 can have an eye shape or an oval shape with the major axisextending between the first and second leaflet connection regions 126,128.

In one embodiment, under antegrade fluid flow (i.e., positive fluidpressure) from the first end 108 towards the second end 110 of the valve100, the valve leaflets 122 can expand toward the inner surface 114 ofthe frame 102 to create an opening through which fluid is permitted tomove. In one example, the valve leaflets 122 each expand to define asemi-tubular structure having an oval cross-section when fluid opens thereversibly sealable opening 116. An example of the open configurationfor the valve is shown in Figs. I A, 1 C and 1 E.

Under a retrograde fluid flow (i.e., negative fluid pressure) from thesecond end 110 towards the first end 108, the valve leaflets 122 canmove away from the inner surface 114 as the valve leaflets 122 begin toclose. In one example, the gap 20 154 allows fluid from the retrogradeflow to develop pressure on a first major face 158 of the valve leaflets122. As fluid pressure develops, the valve leaflets 122 collapse,closing the reversibly sealable opening 116, thereby restrictingretrograde fluid flow through the valve 100. An example of the closedconfiguration for the valve is shown in Figs. IB, ID, and IF.

In an additional embodiment, the first major surface 158 of the valveleaflet 121 further include a concave pocket 160. For example, asillustrated in Figs. IE and IF, the concave pocket 160 can be defined bya predefined portion of the cover 104 that moves relative the frame 102as the valve opens and closes. In one embodiment, the concave pocket 160includes specific dimensions relative a diameter of a vessel into whichthe valve 100 is to be implanted. For example, the concave pocket 160can have a predetermined length-to-width ratio relative the diameter ofthe vessel in which the valve 100 is to be implanted. In one embodiment,the predetermined length-to-width ratio can be defined as:

H=(0.75)(D)

where H is the maximum height 162 of concave pocket 160, and D is adiameter 164 of the valve 100 taken between the first and second leafletconnection regions 126, 128.

Valve 100 provides an embodiment in which the surfaces defining thereversibly sealable opening 116 provide a hi-leaflet configuration(i.e., a bicuspid valve) for valve 100. Although the embodiments inFIGS. 1A-1F illustrate and describe a hi-leaflet configuration for thevalve of the present invention, designs employing a different number ofvalve leaflets (e.g., tri-leaflet valve) maybe possible. For example,additional connection points (e.g., three or more) could be used toprovide additional valve leaflets (e.g., a tri-leaflet valve).

The valve leaflets 122 can have a variety of sizes and shapes. Forexample, each of the valve leaflets 122 can have a similar size andshape. Alternatively, 15 each of the valve leaflets 122 need not have asimilar size and shape (i.e., the valve leaflets can have a differentsize and shape with respect to each other).

In an additional embodiment, the valve leaflets 122 can include one ormore support structures, where the support structures can be integratedinto and/or onto the valve lea±1ets 122. For example, the valve leaf1ets122 can include one or more 20 support ribs having a predeterminedshape. In one embodiment, the predetermined shape of the support ribscan include a curved bias so as to provide the valve leaf1ets 122 with acurved configuration. Support ribs can be constructed of a ±1exiblematerial and have dimensions (e.g., thickness, width and length) andcross-sectional shape that allows the support ribs to be flexible whenthe valve leaflets 122 are urged into an open position, and stiff whenthe valve leaf1ets 122 are urged into a closed position uponexperiencing sufficient back How pressure from the direction downstreamfrom the valve. In an additional embodiment, support ribs can also beattached to frame 102 so as to impart a spring bias to the valveleaflets in either the open or the closed configuration.

As described herein, the cover 104 can be located over at least theinner surface 114 of the frame 102. FIGS. 1A and 1B illustrate anembodiment of this configuration, where the cover extending over theinner surface 114 also forms the valve leaflets 122 as described herein.Numerous techniques may be employed to laminate or bond cover 104 on theouter surface 112 and/or the inner surface 1114 of the frame 102,including heat setting, adhesive welding, application of uniform forceand other bonding techniques. Additionally, the cover 104 may be foldedover the first end 108 of the frame 102 to provide the cover 104 on boththe outer surface 112 and the inner surface 114. Cover 104 can also bejoined to itself and/or the members 118 according to the methodsdescribed in U.S. Patent Application Publication US 2002/0178570 toSogard et al., which is hereby incorporated by reference in itsentirety.

The cover 104 can also be coupled to the connection regions so as toform the valve leaflets, as described herein. In one embodiment, thecover 104 can be in the form of a sheet or a sleeve of material, asdescribed herein, which can be connected to the frame 102.Alternatively, the cover 104 can initially be in the form of a liquidthat can be used to cast and/or form the cover over the frame 102. Otherforms, including intermediate forms, of the cover 104 are also possible.

The cover 104 can be coupled to the frame 102, including the connectionregions 126 and 128, in a variety of ways so as to provide the variousembodiments of the valve of the present invention. For example, avariety of fasteners can be used to couple the cover 104 to the frame102 so as to form the valve I00. Suitable fasteners can include, but arenot limited to, biocompatible staples, glues, sutures or combinationsthereof In an additional embodiment, the cover 104 can be coupled to theframe 102 through the use of heat scaling, solvent bonding, adhesivebonding, or welding cover 104 to either a portion of the cover 104(i.e., itself) and/or the frame 102.

The cover 104, including the valve leaflets 122, may also be treatedand/or coated with any number of surface or material treatments. Forexample, the cover 104 can be treated with one or more biologicallyactive compounds and/or materials that may promote and/or inhibitendothelization and/or smooth muscle cell growth of the cover 104,including the valve leaflets 122. Similarly, the cover 104 may be seededand covered with cultured tissue cells (e.g., endothelial cells) derivedfrom a either a donor or the host patient which are attached to thevalve leaflets 122. The cultured tissue cells may be initiallypositioned to extend either partially or fully over the valve leaflets122.

Cover 104, in addition to forming valve leaflets 122, can also becapable of inhibiting thrombus formation. Additionally, cover 104 mayeither prevent or facilitate tissue ingrowth there through, as theparticular application for the valve 100 may dictate. For example, cover104 on the outer surface 112 may be formed from a porous material tofacilitate tissue ingrowth there through, while cover 104 on the innersurface 114 may be formed from a material or a treated material whichinhibits tissue ingrowth.

FIGS. 3A and 3B illustrate an additional embodiment of the valve 300.Valve 300 includes frame 302 having an open frame configuration and thefirst and second leaflet connection regions 326, 328, as describedherein. The leaflet connection regions 326 and 328 also provide a firstvertex 361 and a second vertex 364, respectively, relative the first end308 of the frame 302.

As illustrated, the outer surface 312 of the frame 302 can provide anumber of frame dimensions. For example, the outer surface 312 of theframe 302 can be viewed as defining a first frame dimension 366 at thefirst end 308 of the frame 302 and a second frame dimension 368 betweenthe first vertex 361 and the second vertex 364 of the frame 302. In oneembodiment, the second frame dimension 368 can have a larger value ascompared to the first frame dimension 366. Other dimensionalrelationships between the first and second frame dimensions 366 and 368are also possible.

In the present embodiment, the differences in the frame dimensions forframe 302 allow portions of the frame members 318 to provide the radialsupport member tor the valve 300. In other words, the radial supportmember of the frame 302 20 can result from the relative shape and sizeof the different portions of the frame members 318. For example, asdescribed herein the first and second frame dimensions 366, 368 can havedifferent sizes, where the outer surface 312 of the frame 302 radiallyarcs from the first frame dimension 366 to the second frame dimension368 so as to provide the radial support member of the frame 302.

So, in the present example the flaring of the of the frame member 318from the first frame dimension 366 to the second frame dimension 368allows the frame member 318 in the region of the first and second vertex361 and 364 to provide the radial support member. In one embodiment, theframe members 318 can be pre and/or post treated to impart the framedimension differences described herein. For example, frame members 318forming the first vertex 361 and the second vertex 364 of the frame 302could be bent to impart the radial flare. In one embodiment, a mandrelhaving a tapering surface could be used to impart the radial flare tothe frame member 318.

The flared first and second vertex 361, 364 of the frame 302 could thenbe heat treated so as to fix the radial flare into the frame member 318.For example, a suitable heat treatment for a nitinol material caninclude heating the frame member 318 to approximately 500 degreesCelsius for approximately two (2) minutes. The frame members 318 canthen be air cooled or quenched. Other material treatments (plasticdeformation, forging, elastic deformation-heat setting) are alsopossible to impart the radial flare as described herein, many of whichare material specific.

In one embodiment, the radial support member illustrated in FIG. 3 canserve to stabilize the valve 300 once positioned at a predeterminedlocation as described 10 herein. In addition, the configuration of theradial support member can allow the first frame dimension 366 and thesecond frame dimension 368 to more closely correspond to each other oncethe valve 300 has been positioned at the predetermined location.

The valve 300 can thither include the cover 304, where both the frame302 and the cover 304 can resiliently radially collapse and expand, asdescribed herein. In the present example, the cover 304 can be locatedover at least the outer surface 312 of the frame 302 and coupled to thefirst and second leaflet connection regions 326 and 328 to form thevalve leaflets 322 (e.g., the first and second valve leaflets 346 and348) and the reversibly sealable opening 316, as described herein. In anadditional embodiment, the cover 304 can also be located over at leastthe inner surface 314 of the frame 302. A further embodiment includesthe cover 304 located over at least the outer surface 312 and the innersurface 314. Anchoring elements (e.g., barbs) and radiopaque markers canalso be included with valve 300, as described herein.

As described herein, the valve leaflets 322 can include the transitionregion 352 where the circumference of the cover 304 changes from a firstcircumference to a second circumference that is smaller than the firstcircumference. The transition region 352 also allows for the gap 354, asdescribed herein, to be formed between the outer surface of the valveleaflets 322 and the inner wall of the vessel in which the valve 300 isimplanted. The valve leaflets 322 can also include the concave pocket360, as described herein. Cover 304 also includes the lip 356 that canhave either a non-planar or a planar configuration, as described herein.

Frame member 318 of the valve frame 302 can also include a variety ofcross-sectional shapes and dimensions. For example, cross-sectionalshapes for the frame member 318 can be as described herein. In addition,the frame member 318 can have two or more cross-sectional shapes, two ormore different dimensions (e.g., a greater width and depth of the framemember 318 for the first and second vertices 361 and 364 as compared tothe remainder of the frame member 318).

FIGS. 4A and 4B illustrate additional embodiments of the valve 400. Asillustrated, the frame 402 includes an open frame configuration and thefirst leaflet connection region 426 and the second leaflet connectionregion 428, as described herein. FIGS. 4A and 4B illustrate embodimentsin which the cover 404 can be positioned at different locations alongthe frame 402 so as to form the valve leaflets 422. For example, in FIG.4A the leaflet connection regions 426 and 428 are located at the firstvertex 461 and the second vertex 464, respectively, relative the firstend 408 of the frame 402. In an additional example, FIG. 4B provides anillustration in which the leaflet connection regions 426 and 428 arepositioned between the end of the frame 402 having the first vertex 461and the second vertex 464 and the first end 408 of the frame 402.

The frame 402 can include multiple structural configurations. Forexample, the frame 402 can include a support frame region 470 that helpsto stabilize and position the valve 400 inside a vessel. In oneembodiment, FIGS. 4A and 4B provide an illustration in which the supportframe region 470 extends from an axis 472 through a mid-point of theframe 402 away from the leaflet connection regions 426 and 428.

As illustrated, the outer surface 412 of the frame 402 can also providea number of frame dimensions. For example, the outer surface 412 of theframe 402 can be viewed as defining the first frame dimension 466 at theaxis 472 of the frame 402 and a second frame dimension 468 measure ateither the first or second end 408, 410 of the frame 402. In oneembodiment, the second frame dimension 468 can have a larger value ascompared to the first frame dimension 466. Other dimensionalrelationships between the first and second frame dimensions 466 and 468are also possible.

In the present embodiment, the differences in the frame 402 dimensionsprovide radial support members for the valve 400. In other words, radialsupport members of the frame 402 result from the relative shape and sizeof the different portions of the frame members 418. For example, asdescribed herein the first and second frame dimensions 466, 468 can havedifferent sizes, where the outer surface 412 of the frame 402 radiallyarcs from the first frame dimension 466 to the second frame dimension468 so as to provide the radial support member of the frame 402. So, inthe present example the flaring of the frame member 418 from the firstframe dimension 466 to the second frame dimension 468 allows the framemember 418 in the region of the first and second vertex 461 and 464 toprovide the radial support member.

In one embodiment, the radial support members illustrated in FIGS. 4Aand 4B can serve to stabilize the valve 400 once positioned at apredetermined location as described herein. In addition, theconfiguration of the radial support member can allow the first framedimension 466 and the second frame dimension 468 to more closelycorrespond to each other once the valve 400 has been positioned at thepredetermined location.

The valve 400 can further include the cover 404, where both the frame402 and the cover 404 can resiliently radially collapse and expand, asdescribed herein. In the present example, the cover 404 can be locatedover at least the inner surface 414 of the frame 402 and coupled to thefirst and second leaflet connection regions 426 and 428 to form thevalve leaflets 422 (e.g., the first and second valve leaflets 446 and448) and the reversibly sealable opening 416, as described herein. In anadditional embodiment, the cover 404 can also be located over at leastthe outer surface 412 of the frame 402. A further embodiment includesthe cover 404 located over at least the outer surface 412 and the innersurface 414. Anchoring elements (e.g., barbs) and radiopaque markers canalso be included with valve 400, as described herein.

Frame member 418 of the valve frame 402 can also include a variety ofcross-sectional shapes and dimensions. For example, cross-sectionalshapes for the frame member 418 can be as described herein. In addition,the frame member 418 can have two or more cross-sectional shapes, two ormore different dimensions (e.g., a greater width and depth of the framemember 418 for one or more of the first and second vertices 461, 464 ascompared to the remainder of the frame member 418).

FIGS. 5A and 5B illustrate an additional embodiment of the valve 500.Valve 500 includes the cover 504 as described herein. The frame 502 ofthe valve 500 further includes a triple wishbone configuration 574. Inone embodiment, the triple wishbone configuration 574 of the frame 502includes a series of interconnected bifurcated members having connectionpoints that act as spring members, as will be described herein. In oneembodin1ent, the interconnection of these members allows for the springforce of aligned springs integrated into the frame 502 to be added inseries so as to increase the spring force potential of the frame 502.

FIG. 5B provides an illustration of the triple wishbone configuration574 for the frame 502 that has been cut to provide it in a planar view.In one embodiment, the frame member 518 in the triple wishboneconfiguration 574 includes a radial support member 534. As illustrated,the radial support member 534 can be in the form of a tubular ring 536that can move radially as the valve 500 radially collapses and expands.

In one embodiment, the tubular ring 536 can provide a spring force(e.g., elastic potential energy) to counter radial compression of theframe 502 towards its uncompressed state. For example, the tubular ring536 has a zig-zag configuration that includes corners 538 that candevelop the spring force when the frame 502 is under compressed. As willbe appreciated, the corners 538 can have a number of configurations,including turns defining angles and/or arcs (e.g., having a radius ofcurvature).

The frame 502 further includes spring members 576 interconnected withthe radial support member 534. As illustrated, the spring members 576are associated with the radial support member 534 adjacent the corners538. For example, the spring members 576 can include extensions 578 thatjoin the radial support member 534 adjacent the corners 538 along acommon plane 580. In the present embodiment, extensions 578 join theradial support member 534 adjacent each corner 538 along the plane 580.

The spring members 576 also include corners 538 that can develop thespring force when the frame 502 is under compressed. As will beappreciated, the corners 538 can have a number of configurations,including turns defining angles and/or 25 arcs (e.g., having a radius ofcurvature). In one embodiment, the corners 538 of the spring members 576also provide the first and second leaflet connection regions 526, 528.In one embodiment, the spring members 576 interconnected with the radialsupport member 534 helps to stabilize the relative positions of theconnection regions 526 and 528 (e.g., limit relative fluctuations of theconnection regions 526 and 528).

The frame 502 can further include dimensional relationships, asdescribed herein, which allow the frame 502 to flare radially outwardrelative the first end 508 of the frame. The valve 500 can furtherinclude the cover 504, where both the frame 502 and the cover 504 canresiliently radially collapse and expand, as described herein. In thepresent example, the cover 504 can be located over at least the innersurface 514 of the frame 502 and coupled to the first and second leafletconnection regions 526 and 528 to form the valve leaflets 522 (e.g., thefirst and second valve leaflets 546 and 548) and the reversibly sealableopening 516, as described herein.

The valve leaflets 522 can further include the transition region 552where the circumference of the cover 504 changes from a firstcircumference to a second circumference that is smaller than the firstcircumference. The transition region 552 also allows for the gap, asdescribed herein, to be formed between the outer surface of the valveleaflets 522 and the inner wall of the vessel in which the valve 500 isImplanted. The valve leaflets 522 can also include the concave pocket560, as described herein. Cover 504 also includes the lip 556 that canhave either a non-planar or a planar configuration, as described herein.

Frame member 518 of the valve frame 502 can also include a variety ofcross-sectional shapes and dimensions. For example, cross-sectionalshapes for the frame member 518 can be as described herein. In addition,the frame member 518 can have two or more cross-sectional shapes, two ormore different dimensions (e.g., a greater width and depth of the framemember 518 for the corners 538 as compared to the remainder of the framemember 518).

FIG. 6 illustrates one embodiment of a system 680. System 680 includesvalve 600, as described herein, reversibly joined to catheter 682. Thecatheter 682 includes an elongate body 684 having a proximal end 686 anda distal end 688, where valve 600 can be located between the proximalend 686 and distal end 688. The catheter 682 can further include a lumen690 longitudinally extending to the distal end 688. In one embodiment,lumen 690 extends between proximal end 686 and distal end 688 ofcatheter 682. The catheter 682 can further include a guidewire lumen 692that extends within the elongate body 684, where the guidewire lumen 692can receive a guidewire for positioning the catheter 682 and the valve600 within a body lumen (e.g., a vein of a patient).

The system 680 can further include a deployment shaft 694 positionedwithin lumen 690, and a sheath 696 positioned adjacent the distal end688. In one embodiment, the valve 600 can be positioned at leastpartially within the sheath 696 and adjacent the deployment shaft 694.The deployment shaft 694 can be moved within the lumen 690 to deployvalve 600. For example, deployment shaft 694 can be used to push valve600 from sheath 696 in deploying valve 600.

FIG. 7 illustrates an additional embodiment of the system 780. Thecatheter 782 includes elongate body 784, lumen 790, a retraction system798 and a retractable sheath 796. The retractable sheath 796 can bepositioned over at least a portion of the elongate body 784, where theretractable sheath 796 can move longitudinally along the elongate body784. The valve 700 can be positioned at least partially within theretractable sheath 796, where the retractable sheath 796 moves along theelongate body 796 to deploy the valve 700.

In one embodiment, retraction system 798 includes one or more wires 701coupled to the retractable sheath 796, where the wires are positioned atleast partially within and extend through lumen 790 in the elongate body784. Wires of the retraction system 798 can then be used to retract theretractable sheath 796 in deploying valve 700. In one embodiment, aportion of the elongate body 784 that defines the guidewire lumen 792extends through the lumen 706 of the valve 700 to protect the valve 700from the movement of the guidewire 709.

FIG. 8 illustrates an additional embodiment of the system 880. Thecatheter 882 includes elongate body 884, an inflatable balloon 803positioned adjacent 20 the distal end 888. The elongate body 884 furtherincludes an inflation lumen 805 longitudinally extending in the elongatebody 884 of the catheter 882 from the inflatable balloon 803 to theproximal end 886. In one embodiment, an inflation pump 807 can bereleasably coupled to the inflation lumen 805 and used to inflate anddeflate the balloon 803.

In the present example, the inflatable balloon 803 can be at leastpartially positioned within the lumen 806 of the valve 800. Theinflatable balloon 803 can be inflated through the lumen 805 with theinflation pump 807 to deploy the valve 800. The system 880 can furtherinclude the guidewire lumen 892 to receive a guidewire 809.

FIGS. 9A-9C illustrate an additional embodin1ent of the system 980. Thesystem 980 includes a tubular sheath 911 having an elongate body 913 anda lumen 915. The system 980 further includes a delivery shaft 917positioned within the lumen 915 of the tubular sheath 911. In oneembodiment, the tubular sheath 911 and the delivery shaft 917 can movelongitudinally relative each other.

System 980 also includes a flexible cover 919 between the tubular sheath911 and the delivery shaft 917. In one embodiment, the flexible cover919 is connected to the tubular sheath 911 and the delivery shaft 917 ata fluid tight seal 921 so as to prevent fluid from outside the system980 entering the lumen 915. As illustrated, the valve 900 can bepositioned over the delivery shaft 915 and the flexible cover 919adjacent a distal end 923 of the delivery shaft 917.

In one embodiment, the tubular sheath 911, the delivery shaft 917 andthe flexible cover 919 can each be formed from a number of differentmaterials. For the tubular sheath examples include, but are not limitedto materials selected from one or more of ePTFE, PTFE, PE, PET,silicone, and polyurethanes. For the delivery shaft 917 examplesinclude, but are not limited to, those selected from a metal, a metalalloy, and/or a polymer. Examples include, but are not limited one ormore of ePTFE, PTFE, PE, nylons, PET, silicone, polyurethanes, andstainless steel (e.g., 316L).

In addition, the delivery shaft 917 can also include a configurationthat imparts sufficient column rigidity to allow it to be pushed and/orpulled through the lumen 915. For example, the delivery shaft 917 can beformed with reinforcing members bound within the body of the deliveryshaft 917 (e.g., an elongate braid of stainless steel co-extruded with apolymer). For the flexible cover 919 examples include, but are notlimited to, materials selected from one or more of cPTFE, PTFE, PE, PET,nylons, and polyurethanes. As will be appreciated, other materials andconfigurations for forming the tubular sheath 911, the delivery shaft917 and the flexible cover 919 are also possible.

As illustrated in FIGS. 9A-9C, the valve 900 can be held in the samerelative location 925 as it is being deployed. As illustrated in FIG.9A, the valve 900, a portion of the flexible cover 919 and the deliveryshaft 917 can be positioned within the lumen 915 of the tubular sheath911. In one embodiment, the configuration illustrated in FIG. 9A allowsthe valve 900 to be delivered in its compressed state to a predeterminedlocation in the lumen of the body. Once at the predetermined location,the sheath 911 can then be moved relative the delivery shaft 917. FIG.9B illustrates a situation where the sheath 911 has been pulled over thevalve 900 location 925 and at least partially over the delivery shaft917.

As illustrated, the flexible cover 919 has a tubular configuration thatfolds back inside of itself (i.e., its lumen) as the tubular sheath 911is drawn over the valve 900 and the delivery shaft 917. In oneembodiment, the lumen 915 of the sheath 911 can contain a lubricatingfluid (e. g., saline) to allow the flexible cover 919 to more easilypass over itself as illustrated. As the tubular sheath 911 continues tobe pulled back relative the delivery shaft 917 until the valve 900 isreleased, as illustrated in FIG. 9C. In one embodiment, the valve 900can include a self-expanding frame that allows the valve 900 to deployat location 925 once released.

The embodiments of the present invention further include methods forforming the valve of the present invention, as described herein. Forexample, the method of forming the valve can include forming the framehaving the leaflet connection regions, as described. The method caninclude providing the radial support member, or members, on the framefor the leaflet connection regions. As described herein, the radialsupport member can include the tubular rings and/or the radial flaresimparted into the leaflet connection regions. The method also includesproviding the cover on the frame, where connecting the cover to theleaflet connection regions provides at least the first leaflet and thesecond leaflet of the valve having surfaces defining the reversiblysealable opening for unidirectional flow of a liquid through the valve.

In an additional example, the valve can be reversibly joined to thecatheter, which can include a process of altering the shape of the valvefrom a first shape, for example an expanded state, to the compressedstate, as described herein. For example, the valve can be reversiblyjoined with the catheter by positioning valve in the compressed state atleast partially within the sheath of the catheter. In one embodiment,positioning the valve at least partially within the sheath of thecatheter includes positioning the valve in the compressed state adjacentthe deployment shaft of the catheter. In an another embodiment, thesheath of the catheter functions as a retractable sheath, where thevalve in the compressed state can be reversibly joined with the catheterby positioning the valve at least partially within the reversible sheathof the catheter. In a further embodiment, the catheter can include aninflatable balloon, where the balloon can be positioned at leastpartially within the lumen of the valve, for example, in its compressedstate.

The embodiments of the valve described herein may be used to replace,supplement, or augment valve structures within one or more lumens of thebody. For example, embodiments of the present invention may be used toreplace an incompetent venous valve and help to decrease backflow ofblood in the venous system of the legs.

In one embodiment, the method of replacing, supplementing, and/oraugmenting a valve structure can include positioning at least part ofthe catheter including the valve at a predetermined location within thelumen of a body. For example, the predetermined location can include aposition within a body lumen of a venous system of a patient, such as avein of a leg.

In one embodiment, positioning the catheter that includes the valvewithin the body lumen of a venous system includes introducing thecatheter into the venous system of the patient using minimally invasivepercutaneous, transluminal catheter based delivery system, as is knownin the art. For example, a guidewire can be positioned within a bodylumen of a patient that includes the predetermined location. Thecatheter, including valve, as described herein, can be positioned overthe guidewire and the catheter advanced so as to position the valve ator adjacent the predetermined location.

As described herein, the position of the one or more radiopaque markerscan be selected so as to provide information on the position, locationand orientation (e.g., axial, directional, and/or clocking position) ofthe valve during its implantation. For example, radiopaque markers canbe configured radially and longitudinally on predetermined portions ofthe valve frame and/or the elongate body of the catheter to indicate notonly a longitudinal position, but also a radial position of the valveleaflets and the valve frame (referred to as a clock position). In oneembodiment, the radiopaque markers are configures to provideradiographic images that indicate the relative radial position of thevalve and valve leaflets on the catheter.

FIGS. 10A-10C provide an illustration of the radiopaque markers 1027associated with the elongate body 1084 of the catheter 1082. Asillustrated, the radiopaque markers 1027 include a radial component 1029and a longitudinal component 1031. Depending upon the radial position ofthe catheter 1082, the radiopaque markers 1027 can provide a differentand distinguishable radiographic image. For example, in a first position1033 illustrated in FIG. 1OA the longitudinal component 1031 of theradiopaque markers 1027 are aligned so as to overlap. As the catheter1082 is rotated, as illustrated in FIGS. 1OB and 1OC, the radiographicimage of the radial component 1029 and/or longitudinal component 1031 ofthe radiopaque markers 1027 change.

The change in the relationship of the radial and longitudinal components1029, 1031 as the catheter 1082 is rotated allows for the relativeposition of the valve, valve frame and valve leaflets to be determinedfrom the radiographic image. For example, the relative position of thefirst and second leaflet connection regions 1026, 1028 could be alignedwith longitudinal component 1031 other radiopaque markers 1027. Thiswould allow the clock position for the valve 1000 to be determined sothat the valve can be positioned in a more natural orientation relativethe compressive forces the valve will experience in situ. In otherwords, the allowing for clocking of the valve 1000 as described hereinallows the valve to be radially positioned in same orientation as nativevalve that it's replacing and/or augmenting.

As will be appreciated, other relative relationships between theradiopaque markers 1027 and the position of the valve 1000 on thecatheter 1082 are possible. So, embodiments of the present inventionshould not be limited to the present example. For example, additionalradiopaque markers 1027 on the valve I000 could be used either alone orin combination with radiopaque markers 1027 on the catheter 1082 to helpin positioning the valve 1000 within a lumen.

The valve can be deployed from the catheter at the predeterminedlocation in a number of ways, as described herein. In one embodiment,valve of the present invention can be deployed and placed in a number ofvascular locations. For example, valve can be deployed and placed withina major vein of a patient's leg. In one embodiment, major veins include,but are not limited to, those of the peripheral venous system. Examplesof veins in the peripheral venous system include, but are not limitedto, the superficial veins such as the short saphenous vein and thegreater saphenous vein, and the veins of the deep venous system, such asthe popliteal vein and the femoral vein.

As described herein, the valve can be deployed from the catheter in anumber of ways. For example, the catheter can include the retractablesheath in which valve can be at least partially housed, as describedherein. Valve can be deployed by retracting the retractable sheath ofthe catheter, where the valve self-expands to be positioned at thepredetermined location. In an additional example, the catheter caninclude a deployment shaft and sheath in which valve can be at leastpartially housed adjacent the deployment shaft, as described herein.Valve can be deployed by moving the deployment shaft through thecatheter to deploy valve from the sheath, where the valve self-expandsto be positioned at the predetermined location. In an additionalembodiment, the valve can be deployed through the use of an inflatableballoon.

Once implanted, the valve can provide sufficient contact and expansionforce against the body lumen wall to prevent retrograde flow between thevalve and the body lumen wall. For example, the valve can be selected tohave a larger expansion diameter than the diameter of the inner wall ofthe body lumen. This can then allow valve to exert a force on the bodylumen wall and accommodate changes in the body lumen diameter, whilemaintaining the proper placement of valve. As described herein, thevalve can engage the lumen so as to reduce the volume of retrograde flowthrough and around valve. It is, however, understood that some leakingor fluid flow may occur between the valve and the body lumen and/orthrough valve leaflets.

In addition, the use of both the radial support member and/or thesupport frame region of the valve can provide a self-centering aspect tovalve within a body lumen. In one embodiment, the self-centering aspectresulting from the radial support member and/or the support frame regionmay allow valve to maintain a substantially coaxial alignment with thebody lumen (e.g., such as a vein) as valve leaflets deflect between theopen and closed configurations so as to better seal the reversibleopening when valve is closed.

While the present invention has been shown and described in detailabove, it will be clear to the person skilled in the art that changesand modifications may be made without departing from the scope of theinvention. As such, that which is set forth in the foregoing descriptionand accompanying drawings is offered by way of illustration only and notas a limitation. The actual scope of the invention is intended to bedefined by the following claims, along with the full range ofequivalents to which such claims are entitled.

In addition, one of ordinary skill in the art will appreciate uponreading and understanding this disclosure that other variations for theinvention described herein can be included within the scope of thepresent invention. For example, the frame 102 and/or the cover 104 canbe coated with a non-thrombogenic biocompatible material, as are knownor will be known.

In the foregoing Detailed Description, various features are groupedtogether in several embodiments for the purpose of streamlining thedisclosure. This method of disclosure is not to be interpreted asreflecting an intention that the embodiments of the invention requiremore features than are expressly recited in each claim. Rather, as thefollowing claims reflect, inventive subject matter lies in less than allfeatures of a single disclosed embodiment. Thus, the following claimsare hereby incorporated into the Detailed Description, with each claimstanding on its own as a separate embodiment.

1.-20. (canceled)
 21. A prosthetic valve, comprising: a stent having aninflow end and an outflow end; wherein the stent include a first regionand a second region, the first region and the second region convergingat an apex; a plurality of leaflets coupled to the stent, wherein one ormore of the leaflets are secured to the stent along the first region andthe second region; and a sealing member disposed along an outer surfaceof the stent.
 22. The prosthetic valve of claim 21, wherein the sealingmember is coupled to the leaflets.
 23. The prosthetic valve of claim 21,wherein the sealing member includes a leaflet material.
 24. Theprosthetic valve of claim 21, wherein a portion of the sealing member isdisposed along an inner surface of the stent.
 25. The prosthetic valveof claim 21, wherein the stent has an inflow end region, an outflow endregion, and a central region disposed between the inflow end region andthe outflow end region.
 26. The prosthetic valve of claim 25, whereinthe inflow end region has an inflow outer diameter, wherein the centralregion has a central outer diameter, and wherein the inflow outerdiameter is greater than the central outer diameter.
 27. The prostheticvalve of claim 25, wherein the outflow end region has an outflow outerdiameter, wherein the central region has a central outer diameter, andwherein the outflow outer diameter is greater than the central outerdiameter.
 28. The prosthetic valve of claim 21, wherein the stentincludes a shape-memory material.
 29. The prosthetic valve of claim 21,wherein the stent includes a nickel-titanium alloy.
 30. The prostheticvalve of claim 21, wherein the stent includes a cobalt alloy.
 31. Theprosthetic valve of claim 21, wherein the inflow end includes ascalloped edge.
 32. The prosthetic valve of claim 21, wherein theoutflow end includes a scalloped edge.
 33. A prosthetic valve,comprising: an expandable stent; a plurality of leaflets coupled to thestent; and a sealing member having a first portion disposed along aninner surface of the stent and a second portion disposed along an outersurface of the stent.
 34. The prosthetic valve of claim 33, wherein thesealing member is coupled to the leaflets.
 35. The prosthetic valve ofclaim 33, wherein the sealing member includes a leaflet material. 36.The prosthetic valve of claim 33, wherein the stent has an inflow endregion, an outflow end region, and a central region disposed between theinflow end region and the outflow end region, and wherein the inflowouter diameter is greater than the central outer diameter.
 37. Theprosthetic valve of claim 36, wherein the outflow outer diameter isgreater than the central outer diameter.
 38. The prosthetic valve ofclaim 33, wherein the stent includes a nickel-titanium alloy.
 39. Theprosthetic valve of claim 33, wherein the stent includes a cobalt alloy.40. A prosthetic valve, comprising: an expandable stent having ascalloped inflow edge, a scalloped outflow edge, a first strut section,a second strut section, and an apex where the first strut section andthe second strut section; a plurality of leaflets coupled to the stentalong at least a portion of the first strut section and at least aportion of the second strut section; and a sealing member disposed alongan outer surface of the stent.